Patent Eligible Method of Treatment/Prevention Claim

Attorney: Yuki Onoe
March 23, 2020

特許適格性を満たす治療/予防方法クレーム の例<... Read more

Battle of the Biologics: Lilly's IPRs Clear Six Teva Patents

Attorney: Lisa M. Mandrusiak
March 5, 2020

Several companies have received FDA approval for antagonist antibodies against calcitonin gene-related peptides. These so-called anti-CGRP biologic drugs are a relatively new type of injectable medication for preventing migraines without side effects.<... Read more

Pharma Claiming Practice Under Fire

Attorney: Richard D. Kelly
February 28, 2020

The Federal Circuit has launched an assault on common claiming techniques in pharma and chemical patents. In October 2019 the Federal Circuit issued two opinions, the first was HZNP Medicines[1] involving the limitation “consisting essentially of” and the second, Idenix[2], striking at Markush Groups. This post concerns the HZNP decision. On February 25 the Federal Circuit denied HZNP’s request for a rehearing and rehearing en banc. According the Drug Patent Watch reported there were 244 drug patents using the language “consisting essentially of,” a number which seems low based on my experience.<... Read more

Persion v. Alvogen: Inherency in Obviousness Attacks

Attorney: Jeffrey B. McIntyre
January 13, 2020

Last month, the Federal Circuit affirmed the District Court of Delaware's decision in Persion Pharmaceuticals v. Alvogen invalidating as obvious two Persion patents claiming methods of treating pain in patients with hepatic impairment (compromised liver functionality) using hydrocodone. Important to the Federal Circuit's decision was the concept of "inherency."... Read more

Not-So-Safe Harbor for Hospira's Erythropoietin Biosimilar

Attorney: Lisa M. Mandrusiak
December 19, 2019

This week the Federal Circuit affirmed Amgen's win against Hospira with respect to Hospira's erythropoietin ("EPO") biosimilar—a drug used to increase red blood cell number—in a Delaware trial where Amgen's U.S. Patent No. 5,856,298 was found to be infringed and not invalid and Amgen was found to be entitled to $70 million for damages associated with its EPO drug Epogen®. Part of the appeal was also dedicated to examining the so-called Safe Harbor provision of 35 U.S.C. § 271(e)(1), where the Federal Circuit agreed with Amgen that Hospira manufactured at least 14 batches of the drug that were not protected by this provision. The Court's decision provides lessons in how companies should be careful to avoid stretching the bounds of the Safe Harbor provision... Read more

Solicitor General on Patent Eligibility

Attorney: Richard D. Kelly
December 16, 2019

The Solicitor General (SG) was invited by the Supreme Court to provide comments on the certiorari petitions filed by Berkheimer and Hikma to review the Federal Circuit's 101 decisions adverse to them. The two briefs have numerous similarities including identifying the Court's decision in Bilski[1]as starting the patent eligibility confusion by not grounding its decision on interpreting the meaning of the 35 U..S.C. 101 terms "process, machine, manufacture, [and] composition of matter." The SG asserts that in Bilski the Court did not ground its decision on the stature terms but instead found three exceptions to be not required by the statutory text: laws of nature, physical phenomenon, and abstract ideas. While these concepts are found earlier Supreme Court decisions, Bilski represented the first time they were used independent of the statutory language or constitutional concept of the "useful arts." The SG then described Mayo[2] as continuing the Court's Bilski practice of not tying patent eligibility to any of the statutory or Constitutional language. Alice[3] characterized the Mayo decisional approach as a two step process.... Read more

The Flip Side of Reasonable Expectation of Success is Unpredictability

Attorney: Daniel J. Pereira, Ph.D.
October 11, 2019

The Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) reversed the USPTO's determination of obviousness in an IPR for patent claims directed to the treatment of non-small cell lung cancer (NSCLC). Just reading the background of the first three or four pages of the decision, it was already apparent that the Court was not going to be affirming the PTAB's decision. Notably:... Read more

Prosecution History Estoppel And Amendments Tangential To Patentability

Attorney: Richard D. Kelly
September 17, 2019

The doctrine of equivalents is an equitable exception to the basic concept that the patent claims define the limit of claim protection. It is intended to prevent one from making an insubstantial change to a claimed invention to avoid infringement which is defined by the function-way-result test. The doctrine is limited by the prior art, dedication to the public, and prosecution history estoppel.... Read more

Method-of-Treatment Claims, Comprising Excluding Certain Patients from Treatment, Found to Be Patent-Ineligible Under 35 U.S.C. § 101

September 13, 2019

On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.... Read more

Non-Limiting Clauses and Written Description Based on Substantially Equivalent Disclosure

Attorney: Daniel J. Pereira, Ph.D.
August 16, 2019

Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion's patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.... Read more